Pneumonia caused by COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10070255 Term: Coronavirus test positive System Organ Class: 10022891 - Investigations MedDRA version: 23.0 Level: LLT Classification code 10084381 Term: Coronavirus pneumonia System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Firazyr®
Product Name: Icatibant (Firazyr®)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ICATIBANT
CAS Number: 130308-48-4
Concentration unit: mg
Sponsors
Dr. Ramón Lleonart Bellfill / Dr. Xavier Corbella Virós
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1-adult patients (18 years or older), both sexes 2-Sars-CoV-2 infection confirmed by PCR less than 4 days before randomization 3-hospitalized with a diagnosis of SARS-CoV-2 pneumonia 4-radiographic evidence of pulmonary infiltrates 5-grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition 6-pO2/FiO2 =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1-imminent death (life expectancy less than 72h) 2-known hypersensitivity or known adverse reactions to the study drug, or its metabolites or excipients of the formulation 3-invasive mechanical ventilation 4-participation in any other clinical trial 5- ALT or AST > 5 x ULN 6-creatinine clearance <50 mL/min using the Cockcroft-Gault formula for participants '18 years old [Cockcroft 1976] 7-patients with recent acute coronary syndrome (<1 month) 8-patients with a history of stroke 9-positive pregnancy test 10-pregnant or lactating woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficacy and safety of icatibant in adult patients admitted to hospitalization units for pneumonia caused by COVID-19, without mechanical ventilation, 10±1 days after starting treatment or discharge from hospital if this occurs before 10 days.;Secondary Objective: Clinical: - time to reach a 48-hour clinical response. -time to reach an afebrile state of 48 hours - long term efficacy - role of drug treatments used in the standard of care (SoC) on efficacy and safety. - duration (days) of the hospital stay. - influence of time (days with illness) on the response to treatment. -incidence of complications related to COVID-19 - incidence of relapse of SARS-CoV-2 pneumonia - incidence of re-entry for any reason - incidence of new consultations to the emergency department for any cause - incidence of mortality from Covid-19 - incidence of all-cause mortality Safety: icatibant: SAEs incidence according to severity up to 28±3 from hospital discharge.;Primary end point(s): Efficacy and safety will be evaluated 10 (±1) days after the start of treatment or at hospital discharge if before day 10: number of patients reaching grade 2 (inpatient, no longer requiring supplemental oxygen and no longer requiring care or grade 1 (hospital discharge) of the ordinal scale of the clinical state of the patient for 48 hours straight* and who has not had an adverse reaction of 3 or 4 or 5 according to the Criteria of Adverse Event Terminology (CTC-AE of the term in Common Terminology Criteria for Adverse Events).;Timepoint(s) of evaluation of this end point: Day 10±1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical: -Number (percentage) of patients who reach grade 2 or grade 1 during the 10 days of to have initiated treatment. - Number (percentage) of patients discharged from hospital who, since discharge The patient must be discharged from the hospital by the 28th day without a relapse or comorbidity related to COVID-19 -Time ('days') until reaching an afebrile state: body temperature less or same as37.5ºC for 48 hours without antipyretic medication -Long-term effectiveness (up to 28 days from discharge, visit 4): "number of patients" who on day 28th of discharge from the hospital continue at grade 2 or grade 1 on the state ordinal scale from the patient's hospital discharge. -Number of days of hospital stay (from the day of initiation of antiviral treatment to discharge from hospital) -complications related to COVID-19 up to 28 days of discharge from hospital (visit 4) -Number (percentage) of patients who need to be admitted to the ICU - Number (percentage) of patients needing supplemental oxygen since discharge hospitalization until the day of discharge - Number (percentage) of patients needing ICU admission and mechanical ventilation -Number (percentage) of patients diagnosed with other nosocomial infection -Number (percentage) of patients requiring hospital readmission within 28 days (visit 4) of discharge Mortality: - Number (percentage) of COVID-19-related deaths up to 28 days from hospital discharge (visit 4) -Number (percentage) of patients who died from any cause up to 28 days after discharge from hospital (visit 4) -Number of days until death safety: -Incidence of adverse events according to their severity and relationship to treatment -Number of patients with a grade 3 or 4 or 5 adverse reaction according to the CTC-EA;Timepoint(s) of evaluation of this end point: Throughout the study. | — |
Countries
Spain
Contacts
Public ContactDr. Ramón Lleonart Bellfill
Dr. Ramón Lleonart Bellfill / Dr. Xavier Corbella Virós
Outcome results
None listed